EMA Draft Reflection Paper Sets Rules for Confirmatory Platform Trials
October 19, 2026
The EMA has released a draft reflection paper on confirmatory platform trials. The Methodology Working Party agreed the draft on 20 August 2026, the CHMP adopted it for consultation on 5 October 2026, and public consultation runs from 19 October 2026 to 31 January 2027.
Platform trials test several treatments in one trial, usually against a shared control, with arms added or dropped over time. The paper (reference EMA/217509/2026) says these designs are likely to play an increasingly important role in marketing authorisation applications. Adaptive designs and common controls, however, make planning, conduct and reporting more complex. The draft is meant to complement existing guidance on multiplicity and adaptive designs, not replace it. Syenza News has also covered the wider EU clinical trials reform agenda.
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